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MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

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ClinicalTrials.gov Identifier: NCT03193736
Recruitment Status : Active, not recruiting
First Posted : June 21, 2017
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
iSTAR Medical

Brief Summary:

The study will evaluate the efficacy and safety of the implant and IOP lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.

The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.


Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Device: MINIject implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open, Multicenter Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : January 30, 2020


Arm Intervention/treatment
Experimental: implant Device: MINIject implant

MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention.

The intervention is to be performed as stand-alone surgery.





Primary Outcome Measures :
  1. reduction in medicated diurnal IOP [ Time Frame: 6 months after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
  • Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System.
  • Glaucoma not adequately controlled

Exclusion Criteria:

  • Diagnosis of glaucoma other than open angle glaucoma
  • Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System.
  • Neovascular glaucoma in the study eye
  • Prior glaucoma surgery in the study eye
  • Clinically significant corneal disease
  • Patients with poor vision

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193736


Locations
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India
Maxivision Eye Hospital
Hyderabad, Telangana, India, 500034
Panama
Clinica de ojos Orillac-Calvo
Panama city, Panama
Sponsors and Collaborators
iSTAR Medical
Investigators
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Study Director: Zubair Hussain iSTAR Medical

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Responsible Party: iSTAR Medical
ClinicalTrials.gov Identifier: NCT03193736     History of Changes
Other Study ID Numbers: ISM04
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Antihypertensive Agents